Director, Clinical Science – Oncology Clinical Development

GSK • Mississauga, ON

2d • $189,750 - $316,250 • Hybrid

About The Position

The Director, Clinical Science – Oncology Clinical Development provides scientific leadership across defined components of study design, conduct, data review, and interpretation within an assigned clinical programme. Reporting to the Clinical Development Lead (CDL), this role operates within the asset-level clinical strategy and contributes scientific depth and rigour to the execution of the Clinical Development Plan (CDP). The Director, Clinical Scientist partners closely with the Senior Scientist and cross-functional teams to support delivery of clinical studies, ensuring scientific quality, data integrity, and robust interpretation of clinical data. This role contributes to both study-level activities and broader programme insights, without holding accountability for asset-level strategy or overall study delivery. This is a scientific individual contributor role requiring deep oncology clinical development expertise, strong analytical and collaboration skills, and the ability to operate effectively within a complex, matrixed environment.

Requirements

• Bachelor’s degree in life sciences or related scientific discipline required
• 5+ years of experience in pharmaceutical/biotechnology industry or related clinical development experience, with a focus on oncology.
• Experience in clinical development from early stage through to regulatory submission, including study design, protocol authoring, and data review/interpretation.
• Experience working within GCP, ICH, and global regulatory guidelines.
• Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions.
• Experience working within cross-functional matrix teams and contributing to clinical decision-making.
• Proven track record of working with investigators, site staff, external experts, CROs, and vendors.

Nice To Haves

• Advanced degree (e.g. MS, PhD, PharmD) strongly preferred in life sciences or a related discipline
• Clinical development experience across multiple phases of development (Phase I–IV)
• Oncology or immuno-oncology clinical development experience.
• Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums.
• Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions.

Responsibilities

• Provide scientific leadership across defined components of study-level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the CDL
• Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables
• Provide scientific insight to the CDL and Senior Scientist to inform asset-level strategy, benefit–risk assessment, and programme-level decision-making
• Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials
• Apply scientific and clinical expertise to analyse and interpret data, ensuring rigour, integrity, and relevance to the target patient population
• Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange
• Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development
• Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with CDP-defined objectives and regulatory requirements
• Author or co-author key study documents (e.g., Clinical Study Proposals), contributing to preparation and presentation at governance forums such as Protocol Review Boards
• Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards
• Provide scientific input into study-level decisions related to protocol implementation and study conduct, within the strategic framework defined by the CDL
• Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites
• Support implementation of study-level Go/No-Go criteria aligned to the asset-level decision framework defined by the CDL
• Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations
• Integrate data from internal and external sources (e.g., literature, competitor data, emerging science) to inform study and programme understanding
• Provide scientific input into data review and interpretation activities, in collaboration with Medical Directors and pharmacovigilance
• Translate study findings into clear scientific insights to inform programme progression and support CDL-led decision-making
• Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and submission materials
• Ensure scientific accuracy, consistency, and quality across study documentation
• Support preparation of regulatory submissions and responses to Health Authority queries
• Contribute to regulatory reporting requirements (e.g., DSURs, INDSRs) and ensure alignment with regulatory standards
• Serve as a core member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery
• Provide scientific expertise to cross-functional discussions, including integrated evidence planning and disease-area forums, as appropriate
• Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators
• Contribute to scientific communications, including publications, congress presentations, and study-related materials
• Identify scientific and operational risks at the study level and provide input into mitigation strategies
• Support and drive implementation of consistent ways of working and process improvements across the programme
• Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities
• Engage in ongoing development to deepen scientific expertise, expand disease-area knowledge, and build broader clinical development capabilities

Benefits

• annual bonus
• eligibility to participate in our share based long term incentive program
• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave

What This Job Offers

• Job Type: Full-time
• Career Level: Director